Full prescribing information

Patient Information
SOVALDITM (soh-VAHL-dee)
(sofosbuvir)
Read this Patient Information before you start taking SOVALDI and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. SOVALDI is used in combination with other antiviral medicines. When taking SOVALDI with ribavirin or in combination with peginterferon alfa and ribavirin you should also read those Medication Guides. The information in this Patient Information Leaflet talks about SOVALDI when it is used with ribavirin and in combination with peginterferon alfa and ribavirin. What is the most important information I should know about SOVALDI?
SOVALDI, in combination with ribavirin or peginterferon alfa and ribavirin,
may cause birth defects or death of your unborn baby. If you are pregnant or
your sexual partner is pregnant or plans to become pregnant, do not take these medicines. You or your sexual partner should not become pregnant while taking SOVALDI with ribavirin or in combination with peginterferon alfa and ribavirin, and for 6 months after treatment is over.  Females and males must use 2 effective forms of birth control during
treatment and for the 6 months after treatment with SOVALDI and
ribavirin or in combination with peginterferon alfa and ribavirin. Talk
to your healthcare provider about forms of birth control that may be used during this time.  Females must have a negative pregnancy test before starting treatment with SOVALDI and ribavirin or in combination with peginterferon alfa and ribavirin, every month while being treated, and for 6 months after your treatment  If you or your female sexual partner becomes pregnant while taking or within 6 months after you stop taking SOVALDI and ribavirin, or SOVALDI in combination with peginterferon alfa and ribavirin, tell your healthcare provider right away. You or your healthcare provider should contact the Ribavirin Pregnancy Registry by calling 1-800-593-2214. The Ribavirin Pregnancy Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant. If you are also infected with HIV and taking medicines to treat your HIV infection, an Antiretroviral Pregnancy Registry is also available at 1-800-258-4263. You should not take SOVALDI alone. SOVALDI should be used together with
ribavirin or in combination with peginterferon alfa and ribavirin to treat chronic
Gilead Sciences
What is SOVALDI?
 SOVALDI is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C infection in adults. It is not known if SOVALDI is safe and effective in children under 18 years of age. Who should not take SOVALDI?
See “What is the most important information I should know about
SOVALDI?”
What should I tell my healthcare provider before taking SOVALDI?
Before taking SOVALDI, tell your healthcare provider if you:
 have liver problems other than hepatitis C infection  have had a liver transplant  have severe kidney problems or you are on dialysis  have HIV  have any other medical condition  are breastfeeding or plan to breastfeed. It is not known if SOVALDI passes into your breast milk. You and your healthcare provider should decide if you will take SOVALDI or breastfeed. You should not do both. Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal supplements.
Other medicines may affect how SOVALDI works. Especially tell your healthcare provider if you take any of the following
medicines:
 carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®)  oxcarbazepine (Trileptal®, Oxtellar XRTM)  phenytoin (Dilantin®, Phenytek®)  phenobarbital (Luminal®)  rifabutin (Mycobutin®)  rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®)  rifapentine (Priftin®)  St. John’s wort (Hypericum perforatum) or a product that contains St. John’s Gilead Sciences
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. How should I take SOVALDI?
 Take SOVALDI exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to.  Do not stop taking SOVALDI without first talking with your healthcare provider. If you think there is a reason to stop taking SOVALDI, talk to your healthcare provider before doing so.  Take SOVALDI 1 time each day with or without food.
 If you miss a dose of SOVALDI, take the missed dose as soon as you
remember the same day. Do not take more than 1 tablet (400 mg) of SOVALDI in a day. Take your next dose of SOVALDI at your regular time the next day.  If you take too much SOVALDI, call your healthcare provider or go to the nearest hospital emergency room right away. What are the possible side effects of SOVALDI?
See “What is the most important information I should know about
SOVALDI?”
The most common side effects of SOVALDI when used in combination with ribavirin include: The most common side effects of SOVALDI when used in combination with peginterferon alfa and ribavirin include:  tiredness  headache  nausea  difficulty sleeping  low red blood cell count Tell your healthcare provider if you have any side effect that bothers you or that These are not all the possible side effects of SOVALDI. For more information, ask Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Gilead Sciences
How should I store SOVALDI?
 Store SOVALDI at room temperature below 86oF (30oC).
 Keep SOVALDI in its original container.
 Do not use SOVALDI if the seal over the bottle opening is broken or missing.
Keep SOVALDI and all medicines out of the reach of children.

General information about the safe and effective use of SOVALDI
It is not known if treatment with SOVALDI will prevent you from infecting another person with the hepatitis C virus during treatment. Talk with your healthcare provider about ways to prevent spreading the hepatitis C virus. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SOVALDI for a condition for which it was not prescribed. Do not give SOVALDI to other people, even if they have the same If you would like more information about SOVALDI, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about SOVALDI that is written for health professionals. For more information, call 1-800-445-3235 or go to www.SOVALDI.com. What are the ingredients in SOVALDI?
Active ingredient: sofosbuvir
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium
stearate, mannitol, and microcrystalline cellulose.
The tablet film-coat contains: polyethylene glycol, polyvinyl alcohol, talc, titanium This Patient Information has been approved by the U.S. Food and Drug SOVALDI is a trademark of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners. 2013 Gilead Sciences, Inc. All rights reserved. Gilead Sciences

Table 1 Recommended Regimens and Treatment Duration for SOVALDI Combination Therapy in HCV Mono-infected and HCV/HIV-1 Co-infected Patients

Patients with Hepatocellular Carcinoma Awaiting Liver Transplantation

Table 2 Ribavirin Dose Modification Guideline for Coadministration with SOVALDI

2.4 Severe Renal Impairment and End Stage Renal Disease

5.1 Pregnancy: Use with Ribavirin or Peginterferon Alfa/Ribavirin

5.2 Use with Potent P-gp Inducers

6.1 Adverse Reactions from Clinical Trials Experience

Table 3 Treatment-Emergent Adverse Events (All Grades) Reported in ≥ 15% of Subjects in Any Treatment Arm

Table 4 Percentage of Subjects Reporting Selected Hematological Parameters

7.1 Potential for Drug Interactions

7.2 Potentially Significant Drug Interactions

Table 5 Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interactiona

7.3 Drugs without Clinically Significant Interactions with SOVALDI

8.8 Patients with HCV/HIV-1 Co-infection

8.9 Patients with Hepatocellular Carcinoma Awaiting Liver Transplantation

8.10 Post-Liver Transplant Patients

8.11 CHC Patients with Genotype 5 or 6 HCV Infection

Table 6 Drug Interactions: Changes in Pharmacokinetic Parameters for Sofosbuvir and the Predominant Circulating Metabolite GS-331007 in the Presence of the Coadministered Druga

Table 7 Drug Interactions: Changes in Pharmacokinetic Parameters for Coadministered Drug in the Presence of Sofosbuvira

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14.1 Description of Clinical Trials

14.2 Clinical Trials in Subjects with Genotype 1 or 4 CHC

Table 8 Response Rates in Study NEUTRINO

Table 9 SVR Rates for Selected Subgroups in NEUTRINO

14.3 Clinical Trials in Subjects with Genotype 2 or 3 CHC

Table 10 Response Rates in Study FISSION

Table 11 SVR Rates by Cirrhosis and Genotype in Study FISSION

Table 12 Response Rates in Study POSITRON

Table 13 SVR Rates for Selected Subgroups by Genotype in POSITRON

Table 14 Response Rates in Study FUSION

Table 15 SVR Rates for Selected Subgroups by Genotype in Study FUSION

Table 16 Response Rates in Study VALENCEa

Table 17 SVR Rates for Selected Subgroup by Genotype in Study VALENCE

14.4 Clinical Trials in Subjects Co-infected with HCV and HIV-1

Table 18 Response Rates in Study PHOTON-1a

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

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